- 20 May 2021
The United States Food and Drug Administration issued its first emergency use Authorization (EUA) for Pfizer. This followed approvals by the UK, Canada, Bahrain, Saudi Arabia and Mexico. Clinical trials have shown this mRNA-based vaccine, and a similar one produced by Moderna, to be between 90-95% effective in preventing Covid-19 infections. However, the one immune from the aftereffects of vaccine is not you but the vaccine itself. Ironical much?
The political slugfest in the pandemic, and the speed in which these vaccines were created, have led many to question whether the administrators were blinded by bellicosity, and if corners were cut to quickly bring a vaccine to market. The vaccine requires ultra-freezing temperatures of -70 degrees for its storage, making its distribution a cumbersome and expensive process. However, that is not what is worrying about this vaccine.
The recent developments in human trials carried out in the United Kingdom have again pushed us into a quandary.Four volunteers who were administered the vaccine, developed by Pfizer-BioNTech in the trial stage developed Bell's palsy, according to US Food and Drug Administration (FDA) regulators. Bell's palsy is a form of temporary facial paralysis.
What exactly is Bell's Palsy?
The symptoms of Bell's palsy include sudden weakness in your facial muscles. Bell's palsy, also known as acute peripheral facial palsy of unknown cause, can occur at any age. The exact cause is unknown. It's believed to be the result of swelling and inflammation of the nerve that controls the muscles on one side of your face. Or it might be a reaction that occurs after a viral infection.For most people, Bell's palsy is temporary. Symptoms usually start to improve within a few weeks, with complete recovery in about six months.
Other side effects noted at vaccination sites
Image Credits: IndiaToday
Human trials in England for the Pfizer-BioNTech vaccine involved 40,000 volunteers and the peer-reviewed scientific journal 'New England Journal of Medicine' suggested the vaccine provokes only mild side effects.
The situation was hardly different from anticipated. Some 80 percent of those vaccinated felt pain at the injection site. Many also felt fatigue, headache and muscle-pain and some had temporarily swollen lymph nodes.
These side effects were more frequent and intense for young people.
India still undecided
India is still unsure about the new vaccine. According to reports, DCGI has asked Pfizer to conduct a local clinical trial for its vaccine due to lack of data on trials for people of the Indian ethnicity. Any vaccine candidate has to give sufficient data on the local population for any vaccine. DGCI still deems the data given by the firm as inadequate and a lot has to be done if Pfizer is to receive a clinical trial waiver. As per global phase III clinical trial data available, from a pool 37,000 participants, Asian ethnic groups were as low as 4.3 percent, and efficacy was even lower 74.4%, compared with an overall world efficacy of 95%.
Pfizer's take on the adverse consequences:
The vaccine has "been tested in the exact same way as we are testing any vaccine that is circulating out there," asserted Pfizer chief executive Albert Bourla. He also added,"the vaccine actually was tested, because of the scrutiny, with even higher standards in terms of how we do things."
Nevertheless health officials in the United Kingdom have become more cautious about the further trials. British authorities warned anyone with "a history of a significant allergic reaction to a vaccine, medicine or food" to avoid taking the vaccine.
Image Credits: NEWS 10 ABC
"For the general population this does not mean that they would need to be anxious about receiving the vaccination," Stephen Evans, pharmacoepidemiology professor at the London School of Hygiene and Tropical Medicine, told Science Media Centre (SMC).
"One has to remember that even things like marmite can cause unexpected severe allergic reactions," he added.
"Finding out the exact cause behind the adverse reactions requires an in-depth study of the specific nature of the reactions and the background medical history of the individuals affected, which cannot be done in a day or two. However, people growing more sceptical over the vaccine is unwarranted and inimical to human well-being.", said Graham Ogg, interim director of Oxford's Medical Research Council Human Immunology Unit.
Against the backdrop of budding optimism, Nigerian government sues Pfizer
Image Credits: Pfizer
The Nigerian government is suing the world’s largest drug manufacturer, Pfizer, for allegedly carrying out illegal trials of an anti-meningitis drug that killed or disabled children.
Nigeria is demanding $7bn in damages from the US company for the families of children it says died or suffered serious side effects when the antibiotic Trovan was administered in the northern state of Kano during a meningitis outbreak in 1996. The Kano state government also has civil and criminal cases pending against Pfizer. The country’s health authorities say that the Pfizer controversy is partly responsible for many families in northern Nigeria refusing to allow their children to be vaccinated against polio. That in turn has been blamed for an outbreak that spread across parts of Africa.
Whether this incident reflects the uncaring attitude of the multinational firm is still undecided but it certainly lays a hitch in the uninterrupted human trials.
The federal government of USA has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines, as per a report in CNBC.
In Februrary itself, a law was passed by HHS secretary Alex Azar, which empowers the pharmaceutical companies towards complete immunity in scenarios where their vaccine fails. Such a blanket immunity law is a rare phenomenon. Such companies also cannot be sued over adverse effects of the product usage.
It is the FDA’s job for approving their product for mass distribution. That is the job of the FDA. Well! You can’t sue the FDA for approving or disapproving a drug either, under the clause of sovereign unity.
The vaccines have been authorized for emergency use because of the pandemic but these vaccines are new and hence their data need to be continuously monitored by world health authorities so they can react immediately. Only close and continued monitoring may yield safe and effective results over a course of time. Hence it would be safer to say that usage of the new vaccine should be avoided, unless absolutely necessary. The one immune from the aftereffects of vaccine is not you but the vaccine itself.